RTSM/eCOA Manager

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🕒 vor 15 Tagen

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

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ICON plc

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1990

💊 Pharmazie

🧬 Biotechnologie

⚕️ Krankenversicherung

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc ist ein globaler Anbieter klinischer, beratender und kommerzieller Dienstleistungen für verschiedene Bereiche der Gesundheits- und Pharmaindustrie. Das Unternehmen bietet ein breites Spektrum an klinischen Lösungen, darunter dezentralisierte klinische Studien, Lösungen zur kardialen Sicherheit, Frühphasen‑Labore sowie medizinische Bildgebung. Darüber hinaus stellt ICON Technologielösungen bereit, die die Arzneimittelentwicklung von den frühen Phasen bis nach der Markteinführung unterstützen. Die therapeutische Expertise umfasst Kardiologie, Onkologie, Innere Medizin und mehr, mit einem starken Fokus auf transformative Therapien wie Zell‑ und Gentherapien sowie Biosimilars. ICON ist als führende Auftragsforschungsorganisation (CRO) anerkannt, liefert regelmäßig Thought Leadership und trägt zu Branchenpublikationen und ‑veranstaltungen bei. Die Services sind darauf ausgerichtet, klinische Studien zu optimieren, Regulatory Intelligence bereitzustellen und mittels robuster Datenanalysen und patientenzentrierter Lösungen Real‑World Evidence zu generieren.

Beschreibung

• Manage day-to-day scientific operations activities, supporting your team to deliver quality outcomes • Support design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems to meet protocol and study requirements • Partner with Clinical Operations and study teams to understand RTSM/IRT/eCOA requirements and ensure alignment on scope, timelines, and deliverables • Develop and manage User Requirement Specifications (URS) and system design documentation • Ensure completion, review, and filing of validation and testing documentation in accordance with quality standards • Provide ongoing RTSM/IRT subject matter expertise to cross‑functional study teams throughout the study lifecycle • Identify, investigate, and resolve system defects and issues in collaboration with Quality, Clinical Operations, and vendors on deviations • Manage change control and emergency system changes • Serve as the primary operational interface between study teams, RTSM vendors, and internal functional teams • Ensure RTSM systems and documentation comply with SOPs and applicable regulations • Oversee quality reviews, validation documentation approval • Managing RTSM user access requests, modifications, and removals, including oversight of periodic access reviews and audit readiness • Alignment with SOPs, regulatory expectations, and system security controls • Support the development and implement standardized RTSM processes • Document end‑to‑end RTSM workflows and associated guidance • Identify process gaps and drive continuous improvement aligned with SOPs and regulations • Ensure RTSM processes support inspection readiness and consistent execution • Develop role‑based RTSM training curricula and materials • Ensure training aligns with processes, system functionality, and regulatory expectations

🎯 Anforderungen

• Bachelor’s degree required (BA/BS) • Minimum 5 years of operational experience in clinical trials within a pharmaceutical company and/or CRO • Strong knowledge of the clinical trial process, with deep expertise in RTSM/IRT (IVRS/IWRS) eCOA systems • End‑to‑end experience managing RTSM system builds and updates • Proven experience leading User Acceptance Testing (UAT) and validation activities • Hands‑on experience working with RTSM/IRT/eCOA vendors; vendor management experience required • Project management experience managing complex, matrixed studies or programs • Familiarity with testing and issue‑tracking tools • Ability to independently identify issues, analyze root causes, and implement solutions in a complex environment • Strong communication, negotiation, and stakeholder‑management skills • Demonstrated leadership, organization, and prioritization capabilities

🏖️ Vorteile

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways